NCT02155738

Brief Summary

The purpose of this study is to determine whether preoperative IV Acetaminophen reduces postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic organ prolapse.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2014

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 19, 2018

Completed
Last Updated

November 19, 2018

Status Verified

October 1, 2018

Enrollment Period

3.2 years

First QC Date

May 29, 2014

Results QC Date

August 28, 2018

Last Update Submit

October 18, 2018

Conditions

Pelvic Organ Prolapse

Keywords

IV acetaminophenPostoperative painPelvic organ prolapse surgeryPelvic organ prolapse repair

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in Postoperative Pain

    VAS or Visual Analog Score is a quantitative measure, in this study, of pain that the subject is currently experiencing. The VAS is presented as a straight line which measures 100mm. The subject is instructed to mark an 'X' through this line reflecting the amount of pain that they are currently experiencing. Zero would indicate no pain, while '100' would indicate the most severe pain ever. Thus the total range for this scale would be 0-100 mm. Higher values indicate more pain; lower value indicate less pain. For this outcome measure, the VAS scores from Baseline and the VAS scores from 24 hours after the end of surgery are being used. The change from baseline in postoperative pain equals the 24 hour VAS score minus the baseline VAS score. The Change from Baseline would be the 24-hour VAS score minus the Baseline VAS score. Higher values indicate more pain; lower values indicate less pain.

    24 hours

  • Cumulative Narcotic Consumption Over the First 24 Hours

    Equianalgesic dosage tables will be used to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. Higher numbers indicate higher narcotic usage.

    First 24 hours

Secondary Outcomes (1)

  • Interference of Pain With Physical, Mental and Social Activities

    1 week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

Drug: IV normal saline

IV Acetaminophen

EXPERIMENTAL

100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

Drug: IV Acetaminophen

Interventions

IV AcetaminophenDRUG
Also known as: Ofirmev
IV Acetaminophen
IV normal salineDRUG

IV normal saline

Also known as: placebo
Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women ≥ 18 years of age
  • scheduled to undergo surgery for POP via a vaginal or minimally invasive (laparoscopic/robotic) route at the University of Pittsburgh Medical Center
  • women anticipated to have a hospital stay ≥24 hours

You may not qualify if:

  • allergy/intolerance to acetaminophen
  • hepatic dysfunction
  • significant alcohol use - defined as patient reported consumption of more than 7 standard drinks per week and/or 3 drinks per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magee-Womens Hospital of the University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Turner LC, Zyczynski HM, Shepherd JP. Intravenous Acetaminophen Before Pelvic Organ Prolapse Repair: A Randomized Controlled Trial. Obstet Gynecol. 2019 Mar;133(3):492-502. doi: 10.1097/AOG.0000000000003102.

    PMID: 30741813DERIVED

MeSH Terms

Conditions

Pelvic Organ ProlapsePain, Postoperative

Interventions

AcetaminophenSaline Solution

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Halina Zyczynski
Organization
University of Pittsburgh
hzyczynski@mail.magee.edu
412-641-1440

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 29, 2014

First Posted

June 4, 2014

Study Start

July 1, 2014

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

November 19, 2018

Results First Posted

November 19, 2018

Record last verified: 2018-10

Locations

US(1)